Clinical Research Associate II - Remote

A biomedical manufacturing company is seeking a Clinical Research Associate who will be primarily responsible for carrying out the responsibilities involved in the execution of IVD clinical trials. This includes site initiation, monitoring and close out of clinical trial sites. Clinical trials may be carried out at various stages or phases in the life cycle of the product including alpha (early stage feasibility), beta and most importantly the clinical studies that validate the product.

ESSENTIAL JOB RESPONSIBILITIES:

• Perform internal performance testing such as proficiency and system testing
• Prepare study protocols investigator manuals, site specific instruction manuals and design case report forms for new and modified products
• Identify potential investigators, prepare site budgets and contract agreements
• Collect, review and process regulatory documents and correspondence from participating trial sites
• Review on-site files, product accountability logs, study supplies inventory, case report forms, and source documents for completeness, accuracy, consistency and compliance; identifies deficiencies and discrepancies and provides remedial training and/or corrective action as required.
• Develop and implement study specific tracking tools to aid in monitoring, regulatory document review, and follow up of issue resolution
• Provide site support for remote/electronic data capture (EDC), review for completeness and consistency, and generate and resolve queries in between monitoring visits
• Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem
• Completion of monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies and recommended action to secure compliance
• Ensure that studies adhere to FDA regulations, Good Clinical Practices, and IVD directives

TRAINING RESPONSIBILITIES: (REQUIRED)

• Complete all assigned and required training satisfactorily and on time
• For people managers, ensure your associates attend and complete all required trainings satisfactorily and on time.

Bachelor's degree in a scientific discipline (Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology), RN or BSN degree or equivalent.

Knowledge and skills: 

Minimum of 3-4 years of experience with In Vitro Diagnostic (IVD) products

Experience in monitoring sites, ability to prioritize and multi-task in a fast-paced environment

Excellent communication and team skills

Effective interpersonal skills

Proficient in Microsoft Office Applications, such as Word, Excel, Access, PowerPoint etc.

Experience in the handling and shipping of Bio hazardous specimens.

Must remain current with regulatory and clinical requirements for diagnostic products and translate the regulatory requirements into clinical trials.

Knowledge of GCP & ICH guidelines and FDA regulations

Working knowledge of the diagnostic field and clinical trial material that is to be studied

30-50% travel required

PREFERRED REQUIREMENTS:

Good understanding of medical terminology, human physiology and laboratory testing

Knowledge of regulatory and clinical practices (GCP, ICH)

Experience with laboratory automation and biological databases

Previous hands-on experience in clinical research at either a diagnostic company/hospital or laboratory

Knowledge of good clinical trial design, including the number and types of subjects and specimens that will be required, the conditions under which specimens must be collected, and the current gold standard for the diagnosis of disease

Must be detailed oriented, with strong time management and organizational skills